FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy
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ClinicalTrials.gov Identifier: NCT00606528 |
Recruitment Status :
Completed
First Posted : February 4, 2008
Last Update Posted : July 25, 2013
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Condition or disease | Intervention/treatment |
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Chronic Hepatitis C Virus Infection | Other: No intervention |
The current therapy for chronic Hepatitis C Virus infection leads to a sustained viral response in only 50% of treated patients. Evidence suggests that a poor response to treatment may be the result of a dysfunction of immunoregulatory mediators including T regulatory cells (Tregs) which secrete FGL2. The aim of this study is to test whether serum FGL2 levels can serve as a biomarker for clinical progress and treatment response in patients undergoing anti-viral therapy for chronic HCV infection.
This study will measure the blood Treg and FGL2 levels of patients with chronic Hepatitis C as they undergo antiviral therapy and will compare those levels to their pre-treatment and post-treatment levels. Treg and FGL2 expression levels will also be measured in patients' liver biopsy tissue when available.
Additionally, this study will examine the main form(s)of Fc Receptor expressed in these patients. The Fc receptor is the hypothesized binding partner of FGL2, and the form expressed in a given patient may determine the downstream effects of FGL2's binding. These data along with clinical, biochemical and virological data will be used to determine whether there is a correlation between FGL2 levels and disease outcome and/or treatment response.
The study will also recruit a group of normal healthy volunteers to give blood samples on two occasions so that the baseline range of FGL2 levels in healthy individuals can be established for comparison.
Study Type : | Observational |
Actual Enrollment : | 54 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | FGL2/Fibroleukin and Hepatitis C Virus Infection: A Predictor of Response to Antiviral Therapy |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | July 2013 |

Group/Cohort | Intervention/treatment |
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Group A
patients with chronic Hepatitis C Virus infection who have not previously received antiviral therapy
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Other: No intervention
None. This is an observational study. |
Group B
Healthy volunteers willing to donate blood on 2 separate occasions
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- correlation between blood FGL2 levels and response to antiviral therapy [ Time Frame: 6 months after the end of treatment ]
- correlation between FGL2 levels and Treg percentage in blood and liver cells [ Time Frame: all time points ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
HCV patient population
Inclusion Criteria:
- able to give written consent
- 18-70 yrs of age, both genders
- willing to use adequate contraception
- diagnosis of chronic HCV infection (of any genotype) based on 2 positive serology tests
- availability of pre- and post-treatment viral load data
- naive to antiviral treatment
- availability of pre-treatment liver biopsy
Exclusion Criteria:
- less than 18 yrs, greater than 70 yrs of age
- pregnancy
- HBV, HDV, or HIV co-infection
- any history of active alcohol or drug abuse
Volunteer Population (Control)
Inclusion Criteria:
- able and willing to provide written informed consent
- willing to provide a brief review of medical history
- 18-70 yrs of age, of either gender
Exclusion Criteria:
- less than 18, greater than 70 yrs of age
- any history of liver, renal, lung, hematological or coronary artery disease
- any history of active alcohol or drug abuse
- any previous diagnosis of HBV, HCV, HDV or HIV

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606528
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada, M5G 2C4 |
Principal Investigator: | Gary Levy, MD | University Health Network, Toronto |
Responsible Party: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00606528 |
Other Study ID Numbers: |
07-0841-T |
First Posted: | February 4, 2008 Key Record Dates |
Last Update Posted: | July 25, 2013 |
Last Verified: | July 2013 |
Antiviral therapy |
Infection Communicable Diseases Hepatitis A Virus Diseases Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic |